Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK 4 MM AGRESSIVE BLADE PLUS; BLADES & BURRS (CROSSCUT)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY MITEK 4 MM AGRESSIVE BLADE PLUS; BLADES & BURRS (CROSSCUT) Back to Search Results
Catalog Number 283419
Device Problem Tip breakage (1638)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/27/2015
Event Type  malfunction  
Event Description
The aggressive blade was used to remove meniscal tissue.By the first activation it showed metal flakes.Thereafter it stopped.Additional information: the surgeon removed the metal shavings with the same shaver.The metal shavings arose only within the first turns.The procedure time was extended with only 2 minutes.
 
Manufacturer Narrative
Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek; however, it is not known if it will be received within the 30 day reporting requirement, therefore depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.Awaiting return.
 
Manufacturer Narrative
The complaint device was received and forwarded to (b)(6) for evaluation.Visual observation of the complaint device reveals no anomalies to the outer shaft.When the inner shaft was examined, signs of friction between the two shafts were seen at the distal end.The friction marks indicates excessive friction, which could lead to metal shavings as reported, confirming the complaint.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed four other similar complaints and one other dissimilar complaint for this lot of devices that were released to distribution.A white paper was performed previously on this failure; the result indicated that the amount of shedding for this product is acceptable.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
 
Event Description
The aggressive blade was used to remove meniscal tissue.By the first activation it showed metal flakes.Thereafter it stopped.The surgeon removed the metal shavings with the same shaver.The metal shavings arose only within the first turns.The procedure time was extended with only 2 minutes.
 
Manufacturer Narrative
This is a follow up report to document device return.A final report will be filed once the device has been investigated.In process.
 
Event Description
The aggressive blade was used to remove meniscal tissue.By the first activation it showed metal flakes.Thereafter it stopped.Additional information: the surgeon removed the metal shavings with the same shaver.The metal shavings arose only within the first turns.The procedure time was extended with only 2 minutes.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
4 MM AGRESSIVE BLADE PLUS
Type of Device
BLADES & BURRS (CROSSCUT)
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
quality department
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
na
raynham MA 02767
Manufacturer Contact
bahaa nashed
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4738587
MDR Text Key5706850
Report Number1221934-2015-00735
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K131191
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 04/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2019
Device Catalogue Number283419
Device Lot NumberM1410010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2015
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date04/07/2015
Device Age5 MO
Event Location Hospital
Date Report to Manufacturer04/07/2015
Date Manufacturer Received04/07/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2014
Is the Device Single Use? Yes
Patient Sequence Number1
-
-